Ignite Creation Date:
2024-05-06 @ 4:07 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04871633
Status:
COMPLETED
Last Update Posted:
2021-05-04
First Post:
2021-01-11
Brief Title:
Effectiveness of Remedesvir in COVID-19 Patients Presenting at Mayo Hospital Lahore
Sponsor:
King Edward Medical University
Organization:
King Edward Medical University
Study Overview
Official Title:
Effectiveness of Remedesvir in SARS-CoV2 Patients Presenting at Mayo Hospital Lahore
Status:
COMPLETED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Currently several drugs including Remdesivir hydroxychloroquine chloroquine ritonavirlopinavir Tocilizumab Arbidol and interferon are under randomised controlled trials RCTs for efficacy andor safety evaluations in patients with COVID-19 in different countries Remdesivir GS-5734 is among these investigational drugs and some studies reported promising results Remdesivir is a nucleotide analogue intravenous pro-drug developed by Gilead Sciences an American biopharmaceutical company for treatment of Ebola virus during the 2014 Ebola outbreak in Western Africa Remdesivir shows broad-spectrum antiviral activity against many RNA viruses including SARS-CoV-2 through blocking RNA polymerase thereby terminating RNA transcription Remdesivir was among the first treatments used in China as the outbreak emerges and it has been reported as potential treatment options for COVID-19 in the USA China and Italy
Detailed Description:
Coronavirus diseases 2019 COVID-19 is caused by a novel β-coronavirus which is named as SARS-CoV-2 SARS-CoV-2 shares 79 RNA sequence identity with severe acute respiratory syndrome coronavirus 2 SARS-COV2 and 50 genomic sequence identity with Middle East respiratory syndrome coronavirus MERS-CoV which caused a major outbreak since 2002 and 2012 in China and Saudi Arabia respectively Despite global containment measures to fight the disease the pandemic continued to rise rapidly spread across the world and resulting in in 105 million confirmed cases and 51391 deaths worldwide as of July 1st 2020 The outbreak of COVID-19 infection has a significant threat to international health the economy psychological stress and mental health worldwide Yet there are no approved vaccines or drugs to make the disease less deadly implying that searching therapeutic options are critical issues to overcome the outbreak Studies are strongly underway to discover rapidly drug candidates for COVID-19 and studies are looking into repurposing drugs that have been used for the treatment of other diseases
Pakistan is badly facing this pandemic too Up till now there are 221896 confirmed cases with 4551 deaths with a death ratio of 21 More than 3000 patients are critical8 In Punjab being allocated as a leading tertiary care centre for COVID-19 patients Mayo hospital Lahore is dealing with each and every category of COVID-19 patients with variable presentations and treating those patients with different investigational drugs in keeping with other countries to find the best possible treatable drug
US Food and Drug Administration FDA has issued an emergency use authorisation EUA of the antiviral drug remdesivir for the treatment of patients with COVID-19 Although clinical trials have showed remdesivir as a treatment option for COVID-19 results are controversial Thats why we need to conduct a trial in our part of the world too to see its effectiveness in patients presenting with Covid-19
Remdesivir has been recently approved by CEAG Corona Expert Advisory Group for COVID patient is Mayo hospital Remdesivir has never been used before in any public sector hospital in Punjab Investigators aim to do this study in Mayo hospital Lahore to check the efficiency of this drug in COVID-19 patients in Mayo hospital Lahore
OBJECTIVE
The objective of the study is to evaluate the effectiveness of remdesivir in patients with COVID-19 presenting to Mayo Hospital Lahore
OUTCOME AND UTILIZATION
To date no therapy has demonstrated efficacy for patients with COVID-19This study will help in finding any definite role of Remdesivir in COVID -19 patients who are severely ill Although data from several international ongoing randomized controlled trials will soon provide more informative evidence regarding the safety and efficacy of remdesivir for COVID-19 but this needs to be evaluated in local arena too
Pakistan is badly facing this pandemic too Up till now there are 221896 confirmed cases with 4551 deaths with a death ratio of 21 More than 3000 patients are critical8 In Punjab being allocated as a leading tertiary care centre for COVID-19 patients Mayo hospital Lahore is dealing with each and every category of COVID-19 patients with variable presentations and treating those patients with different investigational drugs in keeping with other countries to find the best possible treatable drug
US Food and Drug Administration FDA has issued an emergency use authorisation EUA of the antiviral drug remdesivir for the treatment of patients with COVID-19 Although clinical trials have showed remdesivir as a treatment option for COVID-19 results are controversial Thats why we need to conduct a trial in our part of the world too to see its effectiveness in patients presenting with Covid-19
Remdesivir has been recently approved by CEAG Corona Expert Advisory Group for COVID patient is Mayo hospital Remdesivir has never been used before in any public sector hospital in Punjab Investigators aim to do this study in Mayo hospital Lahore to check the efficiency of this drug in COVID-19 patients in Mayo hospital Lahore
OBJECTIVE
The objective of the study is to evaluate the effectiveness of remdesivir in patients with COVID-19 presenting to Mayo Hospital Lahore
OUTCOME AND UTILIZATION
To date no therapy has demonstrated efficacy for patients with COVID-19This study will help in finding any definite role of Remdesivir in COVID -19 patients who are severely ill Although data from several international ongoing randomized controlled trials will soon provide more informative evidence regarding the safety and efficacy of remdesivir for COVID-19 but this needs to be evaluated in local arena too
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None